Ambulatory Patients in the Dep. of Medical GastroenterologyINFO-INCT03094598
Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials
A study testing Leaflet, Brochure and Booklet in people with Ambulatory Patients in the Dep. of Medical Gastroenterology and Ambulatory Patients in the Dep. of Gynecology, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 2 sites in Denmark.
Trial summary
The purpose of this study is to investigate the knowledge about randomised clinical trials and the attitude towards clinical research among Danish outpatients. The INFO Trial was designed as a randomised, parallel group, observer-blinded trial comparing three types of written information (a leaflet, a brochure, and a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulatory Patients in the Dep. of Medical Gastroenterology, Ambulatory Patients in the Dep. of Gynecology, Ambulatory Patients in the Dep. of Orthopedic Surgery
- What is being tested?
- Leaflet, Brochure and Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 1996to Dec 1996
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient
- Ability to read and understand Danish and written informed consent.
Who cannot join
- Patients under 18 years of age and patients enrolled in another clinical trial on the same day.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen Trial Unit, Centre for clinical intervention research
Copenhagen
Hvidovre University Hospital
Hvidovre, 2650
About this study
Official title: The INFO-I Trial: A Randomised Trial Assessing the Impact of Written Information on Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials
The purpose of this study is to investigate the knowledge about randomised clinical trials and the attitude towards clinical research among Danish outpatients. The INFO Trial was designed as a randomised, parallel group, observer-blinded trial comparing three types of written information (a leaflet, a brochure, and a booklet) to each other and to a no intervention group.
Read the detailed description
To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomised clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about and attitude toward randomised clinical trials was assessed in a randomised, parallel group, evaluator-blinded trial among 415 outpatients recruited from four departments at a university hospital in Copenhagen. The patients were randomised to the following groups: control (no intervention), leaflet, brochure, or booklet in a 1:1:1:1 ratio. Knowledge (KN) was assessed by a 17-item multiple-choice questionnaire and attitude (AT) was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed.
Assessment of scales for knowledge and attitudes was performed using Rasch analysis and Cronbach 's alpha. Associations between demographic variables, knowledge score and attitude score were examined using analysis of variance.
- Conditions
- Ambulatory Patients in the Dep. of Medical Gastroenterology, Ambulatory Patients in the Dep. of Gynecology, Ambulatory Patients in the Dep. of Orthopedic Surgery, Ambulatory Patients in the Dep. of Urology
- Being tested
- Leaflet, Brochure, Booklet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeafletOther
The length is 1.5 A4 pages, Flesch's Reading Ease Score (RES) is 57 (fairly difficult, comparable to a quality magazine), and Human Interest Score (HIS) is 37 (interesting, comparable to a digest magazine).
BrochureOther
The length is 2.5 A4 pages, RES is 43 (difficult, comparable to an academic magazine), and HIS is 25 (interesting, comparable to a digest magazine).
BookletOther
The length is 12 A4 pages, RES is 11 (very difficult, comparable to a scientific magazine), and HIS is 22 (mildly interesting, comparable to a trade magazine).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Leaflet | Experimental | The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability. Receives: Other: Leaflet |
| Brochure | Experimental | The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information. Receives: Other: Brochure |
| Booklet | Experimental | The booklet is also based on practical communication experience, but give more elaborate explanations. Receives: Other: Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge (KN) scores
Change in knowledge (KN) scores scores between entry and follow-up.
Measured: 2 weeks
Secondary outcomes (1)
Attitude (AT) (total) scores
Change in attitude (AT) (total) scores between entry and follow-up.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startOct 1996
- Primary completionDec 1996
- Study completionDec 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ambulatory Patients in the Dep. of Medical GastroenterologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Info Trial Group, Charlotte Behnke, Pia Caspersen, Dorte Fischer, Rolf I. Hansen, Karin Jensen, Birthe Klarskov, Lars K. Møller, Kirsten Obel, Sten N. Rasmussen, Pia Munkholm, Ju-ri Rumessen, Stig Sonne-Holm
- Responsible party
- Sponsor
- Investigators
- Kim Krogsgaard, MD, Principal investigator, Copenhagen Trial Unit - Centre for Intervention Research, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094598
- Sponsor's protocol ID
- Protokol: 1996-10-31/KK.df
- Other IDs
- 1996-DP-18-RKF-3-INFO-I
- Acronym
- INFO-I
- Status last verified
- Mar 2017
- First submitted
- 25 Aug 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan for data sharing
Publications
Kruse AY, Kjaergard LL, Krogsgaard K, Gluud C, Mortensen EL, Gottschau A, Bjerg AM. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The INFO trial group. Control Clin Trials. 2000 Jun;21(3):223-40. doi: 10.1016/s0197-2456(00)00048-9.
PubMed 10822120Kjaergaard LL, Kruse AY, Krogsgaard K, Gluud CN, Mortensen EL, Gottschau A, Bjerg AM. Outpatients' knowledge about and attitude towards clinical research and randomized clinical trials. The INFO Trial Group. Dan Med Bull. 1998 Sep;45(4):439-43.
PubMed 9777295
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INFO-I Trial: A Randomised Trial Assessing the Impact of Written Information on Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials
- ClinicalTrials.gov ID
- NCT03094598
- Acronym / sponsor ID
- INFO-I / Protokol: 1996-10-31/KK.df
- Conditions
- Ambulatory Patients in the Dep. of Medical Gastroenterology, Ambulatory Patients in the Dep. of Gynecology, Ambulatory Patients in the Dep. of Orthopedic Surgery, Ambulatory Patients in the Dep. of Urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention ResearchUniversity, hospital or other
- Collaborators
- The Info Trial Group, Charlotte Behnke, Pia Caspersen, Dorte Fischer, Rolf I. Hansen, Karin Jensen, Birthe Klarskov, Lars K. Møller, Kirsten Obel, Sten N. Rasmussen, Pia Munkholm, Ju-ri Rumessen, Stig Sonne-Holm
- Study start
- Oct 1996
- Primary completion
- Dec 1996 (actual)
- Study completion
- Dec 1996 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the knowledge about randomised clinical trials and the attitude towards clinical research among Danish outpatients. The INFO Trial was designed as a randomised, parallel group, observer-blinded trial comparing three types of written information (a leaflet, a brochure, and a booklet) to each other and to a no intervention group.
Detailed description
To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomised clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about and attitude toward randomised clinical trials was assessed in a randomised, parallel group, evaluator-blinded trial among 415 outpatients recruited from four departments at a university hospital in Copenhagen. The patients were randomised to the following groups: control (no intervention), leaflet, brochure, or booklet in a 1:1:1:1 ratio. Knowledge (KN) was assessed by a 17-item multiple-choice questionnaire and attitude (AT) was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed.
Assessment of scales for knowledge and attitudes was performed using Rasch analysis and Cronbach 's alpha. Associations between demographic variables, knowledge score and attitude score were examined using analysis of variance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Leaflet | Experimental | Other: LeafletThe leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability. |
| Brochure | Experimental | Other: BrochureThe brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information. |
| Booklet | Experimental | Other: BookletThe booklet is also based on practical communication experience, but give more elaborate explanations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatient
- Ability to read and understand Danish and written informed consent.
Key exclusion criteria (1 listed)
- Patients under 18 years of age and patients enrolled in another clinical trial on the same day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeafletThe length is 1.5 A4 pages, Flesch's Reading Ease Score (RES) is 57 (fairly difficult, comparable to a quality magazine), and Human Interest Score (HIS) is 37 (interesting, comparable to a digest magazine). | Other | Leaflet |
| BrochureThe length is 2.5 A4 pages, RES is 43 (difficult, comparable to an academic magazine), and HIS is 25 (interesting, comparable to a digest magazine). | Other | Brochure |
| BookletThe length is 12 A4 pages, RES is 11 (very difficult, comparable to a scientific magazine), and HIS is 22 (mildly interesting, comparable to a trade magazine). | Other | Booklet |
Primary outcome
Knowledge (KN) scores
Time frame: 2 weeks
Change in knowledge (KN) scores scores between entry and follow-up.
1 secondary outcome
Attitude (AT) (total) scores
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Results publication: PubMed 10822120Kruse AY, Kjaergard LL, Krogsgaard K, Gluud C, Mortensen EL, Gottschau A, Bjerg AM. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The INFO trial group. Control Clin Trials. 2000 Jun;21(3):223-40. doi: 10.1016/s0197-2456(00)00048-9.
- Results publication: PubMed 9777295Kjaergaard LL, Kruse AY, Krogsgaard K, Gluud CN, Mortensen EL, Gottschau A, Bjerg AM. Outpatients' knowledge about and attitude towards clinical research and randomized clinical trials. The INFO Trial Group. Dan Med Bull. 1998 Sep;45(4):439-43.
- Individual participant dataSharing planned: No. No plan for data sharing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Krogsgaard, MD principal investigator
Copenhagen Trial Unit - Centre for Intervention Research, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leaflet, Brochure and Booklet in people with Ambulatory Patients in the Dep. of Medical Gastroenterology and Ambulatory Patients in the Dep. of Gynecology, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (KN) scores (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094598, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.